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Promex Distribution LLC

FDA Regulatory Profile

Promex Distribution LLC has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Aug 10, 2022 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections5Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 10, 2022Mcallen, TXFood/CosmeticsNo Action Indicated (NAI)3014479659
Nov 16, 2021Mcallen, TXFood/CosmeticsOfficial Action Indicated (OAI)3014479659
Feb 1, 2021Mcallen, TXFood/CosmeticsOfficial Action Indicated (OAI)3014479659
Feb 11, 2020Mcallen, TXFood/CosmeticsOfficial Action Indicated (OAI)3014479659
Aug 23, 2018Mcallen, TXFood/CosmeticsVoluntary Action Indicated (VAI)3014479659

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3014479659Mcallen, TX5Aug 10, 2022

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.